All eight clinical sites in Asia are actively recruiting. The study is being conducted in Asian countries where there are high rates of gastric cancer and where patients have difficulty accessing expensive antibody treatments such as Herceptin and Perjeta.
Imugene Limited, an immuno-oncology company has announced it has commenced its first patient dosing of the Phase 1b/2 clinical study of its HER-Vaxx immunotherapy in gastric cancer. Patients are currently being enrolled at eight key cancer hospital sites in Asia, including Hong Kong, Thailand and Taiwan.
Imugene is testing a therapeutic anti-cancer vaccine called HER-Vaxx, in HER2+ gastric cancer patients.
Principal investigator, Univ. Professor Dr. Dr.h.c. Christoph Zielinski and Chairman, Clinical Division of Oncology and Department of Medicine at the Medical University Vienna stated, "Our team is excited to be part of this important study and the search for effective new treatments for gastric cancer as there are limited options for patients."
Imugene Chief Executive Officer, Leslie Chong said, "The successful start of this study represents an important development milestone for our business and medical professionals seeking new ways to treat patients with gastric cancer."
HER-Vaxx is designed to produce a strong antibody response against a growth signal receptor protein called HER2 which is found on the cell surface in gastric cancers.
The study is being conducted in Asian countries where there are high rates of gastric cancer and where patients have difficulty accessing expensive antibody treatments such as Herceptin and Perjeta.
Based on preclinical data recently published, Imugene believes HER-Vaxx will stimulate a rapid and strong immune response against cancerous cells.
The Phase 1b lead-in trial is testing three different doses of the HER-Vaxx vaccine with up to 18 patients (three groups up to six patients) in combination with chemotherapy across eight trial sites.
The key endpoints are to identify the optimal dose of HER-Vaxx for the Phase II part of the study, and confirm safety. Researchers will monitor the patient's immune responses to the vaccine.
The current study will be followed by a randomised open label Phase II study with around 68 patients with metastatic gastric cancer overexpressing HER2. The study will be randomised into two arms of either HER-Vaxx plus standard-of-care (chemotherapy) or standard-of-care alone. The endpoints of this randomised trial will be safety, immune response, progression-free survival and overall survival.
 Joshua Tobias, Joanna Jasinska, Karin Baier, Michael Kundi, Nicholas Ede, Christoph Zielinski, Ursula Wiedermann, Enhanced and long term humoral and cellular immunogenicity of a Her-2/neu hybrid-CRM197 peptide vaccine, using the Th1-driving adjuvant Montanide, BMC cancer, 2017, 17, 118 click here to view